prulacabtagene leucel (ADI-001) / Adicet Bio - LARVOL DELTA

A phase 1 study of ADI-001: Anti-CD20 CAR-engineered allogeneic gamma delta (γδ) T cells in adults with B-cell malignancies. (ASCO 2022) - P1 | "All patients received conditioning therapy with fludarabine and cyclophosphamide...One patient received prior anti-CD19 CAR T cells therapy with lisocabtagene maraleucel... ADI-001 γδ CAR T cells were well tolerated, with a favorable safety profile and encouraging preliminary efficacy. Patients who achieved CR at day 28 appeared to be disease free during further follow-up at month-3."

Clinical • IO biomarker • P1 data • Diffuse Large B Cell Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Phase 1 Study of ADI-001: Anti-CD20 CAR-Engineered Allogeneic Gamma Delta1 (γδ) T Cells in Adults with B-Cell Malignancies (TCT-ASTCT-CIBMTR 2023) - "Preliminary efficacy showed encouraging CR rate and sustained durability in patients, including those previously exposed to CAR T therapy. Additional data will be presented at the meeting."

Clinical • IO biomarker • P1 data • CNS Disorders • Diffuse Large B Cell Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Adicet Bio Announces Completion of Last Patient Visit for Planned Analysis of prula-cel (formerly ADI-001) Study in Patients with Systemic Lupus Erythematosus With or Without Lupus Nephritis… (Businesswire) - "The Company expects to report topline data in September 2026. The Company plans to host an investor webcast upon release of the topline data to discuss the results and next steps for the program."

P1 data • Trial status • Immunology • Systemic Lupus Erythematosus

Prula-cel Autoimmune Program on Track for 3Q 2026 Data Readout (Businesswire) - "Potential registrational trial design in development following FDA interaction. Additional information regarding potential pivotal trial design is expected as part of the upcoming prula-cel clinical update later this month. Expanded prula-cel administration into outpatient setting following FDA alignment, enabling LN and other SLE patients in current and future studies to receive treatment in the outpatient setting. Clinical update in patients with systemic sclerosis expected in the fourth quarter of 2026."

Clinical protocol • Commercial • P1 data • Immunology • Systemic Lupus Erythematosus • Systemic Sclerosis

Clinical update anticipated in mid-2026 for Phase 1 autoimmune program evaluating prulacabtagene leucel (prula-cel, formerly ADI-001) with at least 20 lupus nephritis (LN) and systemic lupus erythematosus (SLE) patients with a minimum of six months follow-up (CRISPR Therap Press Release) - "Adicet also intends to meet with the FDA in the second quarter of 2026 to inform potential pivotal trial design. Subject to regulatory clearance to proceed, the Company expects to initiate start up activities for a pivotal program in LN or LN and SLE patients in the second half of 2026. In addition, following alignment with the FDA in November 2025, LN and SLE patients in the ongoing Phase 1 study and future studies may be dosed with prula-cel in the outpatient setting. The Company plans to provide a clinical update in patients with systemic sclerosis in the second half of 2026. The Phase 1 trial of prula-cel in RA is designed to assess two lymphodepletion approaches, cyclophosphamide alone and in combination with fludarabine. The next update on this trial is expected in the second half of 2026."

FDA event • New trial • P1 data • Trial status • Lupus Nephritis • Rheumatoid Arthritis • Systemic Lupus Erythematosus • Systemic Sclerosis

Long-term Follow-up Study of Allogeneic Gamma Delta (γδ) CAR T Cells (clinicaltrials.gov) - P=N/A | N=50 | Active, not recruiting | Sponsor: Adicet Therapeutics | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease (clinicaltrials.gov) - P1 | N=180 | Enrolling by invitation | Sponsor: Adicet Therapeutics | Recruiting ➔ Enrolling by invitation

Enrollment status • ANCA Vasculitis • CNS Disorders • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Phase 1 trial of prula‑cel demonstrating strong enrollment momentum across multiple autoimmune indications, with next clinical update expected in the first half of 2026. (PharmiWeb) - "...plans to provide an additional clinical update from the study in the second half of 2026. Adicet plans to meet with the FDA in the second quarter of 2026 to inform potential pivotal trial design. Subject to regulatory clearance to proceed, the Company expects to initiate a pivotal study in LN or LN and SLE patients in the second half of 2026."

FDA event • New trial • Trial status • Lupus Nephritis • Systemic Lupus Erythematosus

Phase 1 study underway in treatment-refractory rheumatoid arthritis (RA) patients to evaluate the potential to reduce conditioning requirements. (PharmiWeb) - "The primary objective of the study is to assess the safety and tolerability of prula-cel, with secondary objectives including evaluation of cellular kinetics, pharmacodynamics, and disease activity scores. The next clinical update on this trial is expected in the second half of 2026."

Trial status • Rheumatoid Arthritis

A Phase 1 Study of ADI-001 in Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: Adicet Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Expansion, Persistence and Pharmacodynamic Profile of ADI-001, a First-in-Class Allogeneic CD20-Targeted CAR Gamma Delta T Cell Therapy, in Patients with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma (ASH 2023) - P1 | "ADI-001 Cmax and D28 persistent exposure were comparable to, or exceeded, those demonstrated by alternative allogeneic CAR T therapies and approved autologous CD19 CAR T therapies. Favorable clinical responses were also associated with higher mean and median peak of ADI-001 cells."

Clinical • PK/PD data • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL15

Enrollment ongoing in ADI-001 Phase 1 program (Businesswire) - "Adicet is actively enrolling patients in its Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases which include: LN, SLE, SSc, IIM, SPS and AAV. Adicet expects to provide an LN and SLE clinical update as well as an SSc clinical update in the first half of 2026."

Trial status • ANCA Vasculitis • Immunology • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis

Adicet Bio Announces First Patient Dosed in Phase 1 Clinical Trial of ADI-001 in Treatment-Refractory Rheumatoid Arthritis (RA) (Businesswire) - "The Phase 1 study is designed to evaluate the safety, tolerability and preliminary efficacy of ADI-001 in patients with treatment-refractory RA....Preliminary clinical data from the Phase 1 trial expected in 2H/2026."

P1 data • Trial status • Rheumatoid Arthritis

Anticipated development plans for ADI-001… (Businesswire) - "Second half of 2026: SLE and LN clinical update; Clinical update in SSc; Clinical update in RA with cyclophosphamide/fludarabine vs cyclophosphamide only conditioning; Potential clinical update in other autoimmune indications."

Clinical • Lupus Nephritis • Rheumatoid Arthritis • Systemic Lupus Erythematosus • Systemic Sclerosis

Adicet plans to request a meeting with the U.S. Food and Drug Administration (FDA) in 1Q/2026 to inform Phase 2 pivotal trial design with a study anticipated to commence in 2Q/2026 (Businesswire)

FDA event • New P2 trial • Lupus Nephritis • Systemic Lupus Erythematosus

Adicet Bio Announces Positive Preliminary Data from ADI-001 Phase 1 Study in Patients with Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) (Businesswire) - "100% of patients in the LN cohort achieved renal response, including three complete responses and DORIS remissions, and two partial responses, with all responses ongoing. 100% of patients saw rapid and sustained reductions in SLEDAI-2K and PGA scores, highlighting ADI-001's potential durable effect on a broad range of lupus symptoms."

P1 data • Lupus Nephritis • Systemic Lupus Erythematosus

A Phase 1 Study of ADI-001 in Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=25 | Not yet recruiting | Sponsor: Adicet Therapeutics

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Adicet Bio Announces First Systemic Sclerosis (SSc) Patient Dosed in Ongoing Phase 1 Clinical Trial of ADI-001 in Autoimmune Diseases (Businesswire) - "Adicet Bio...announced that the first systemic sclerosis (SSc) patient has been dosed in the second cohort of the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases....'We are pleased with the enrollment in our LN and SLE cohort and look forward to sharing preliminary clinical data from the trial in the second half of 2025'."

P1 data • Trial status • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis

GLEAN-1: A Phase 1 Study of ADI-001 in B Cell Malignancies (clinicaltrials.gov) - P1 | N=34 | Terminated | Sponsor: Adicet Therapeutics | N=78 ➔ 34 | Trial completion date: Dec 2027 ➔ Feb 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jul 2025 ➔ Feb 2025; Terminated - Halted Prematurely

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Adicet Bio Reports First Quarter 2025 Financial Results and Provides Business Updates (Businesswire) - "In April 2025, Adicet expanded enrollment in its Phase 1 trial to include patients with SLE, in addition to ongoing enrollment in LN. The Company expects to initiate enrollment for patients with systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) in the Phase 1 trial in 3Q/2025. Preliminary clinical data from the trial is expected in 2H/2025, subject to study site initiation and patient enrollment."

P1 data • Trial status • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Adicet Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights Recent Company Progress (Businesswire) - "Phase 1 clinical trial of ADI-001 in autoimmune diseases ongoing; on track to report preliminary clinical data from lupus nephritis (LN) patient cohort in 1H25. Additional LN clinical data and preliminary clinical data from other autoimmune patient cohorts anticipated in 2H25. Initiation of ADI-001 Phase 1 clinical trial patient enrollment in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) expected in 2Q25; anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) patient enrollment expected to be initiated in 2H25."

Enrollment status • P1 data • ANCA Vasculitis • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Systemic Sclerosis (SSc) (Businesswire) - "Adicet Bio, Inc...today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with systemic sclerosis (SSc)."

Fast track • Systemic Sclerosis

Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Refractory Systemic Lupus Erythematosus (SLE) with Extrarenal Involvement (Businesswire) - "Adicet Bio, Inc...today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement."

Fast track • Systemic Lupus Erythematosus

A Phase 1 Study of ADI-001 in Autoimmune Disease (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Adicet Therapeutics | N=40 ➔ 180

Enrollment change • ANCA Vasculitis • CNS Disorders • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Adicet Bio Provides Corporate Update and Highlights Expected 2025 Milestones (Businesswire) - "In November 2024, Adicet announced the dosing of the first LN patient in the Phase 1 trial of ADI-001 in autoimmune diseases. The Company expects to initiate enrollment for patients with SLE, SSc, IIM, and SPS in the first quarter of 2025, and for patients with AAV in the second half of 2025. Preliminary clinical data from the Phase 1 trial of ADI-001’s LN patient cohort are anticipated in the first half of 2025. Preliminary data from the Phase 1 trial’s other patient cohorts are expected in the second half of 2025."

P1 data • Trial status • ANCA Vasculitis • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis